JP6967453B2 - Sensor for use with drug delivery devices - Google Patents

Description

The present invention relates to a sensor assembly that is integral with or detachably attached to a drug delivery device such as an injection pen.

There are various diseases that require regular treatment by injecting drugs. Such injections are made using injection devices utilized by healthcare professionals or the patients themselves. As an example, type 1 and type 2 diabetes are treated, for example, once or several times daily by the patient himself injecting an insulin dose. For example, a pre-filled disposable insulin pen is used as an injection device. Alternatively, a reusable pen is used. The reusable pen allows you to replace an empty drug cartridge with a new one. Both pens come with a set of one-time needles that are replaced before use. The insulin dose to be injected is then manually selected, for example, by turning the dose knob (dial setting) on the insulin pen and checking the actual dose with the insulin pen dose window or display device. The dose is then injected by inserting a needle into the appropriate skin area and pressing the injection button on the insulin pen. Injection devices, such as information on the type and dose of insulin injected, so that insulin injections can be monitored, for example, to prevent mishandling of insulin pens or to keep track of already applied doses. It is desirable to evaluate information related to the condition and / or usage of.

For example, Patent Document 1 describes providing an auxiliary device comprising a mating unit for releasably attached to an injection / drug delivery device. The device includes a camera and is configured to perform optical character recognition (OCR) on captured images visible through the dose window of the injection pen, thereby confirming the dose of drug dialed to the injection device. NS.

WO2011 / 117212

A first aspect of the present invention provides an optical decoding system, which system is:
With an optical sensor that is integral with or attachable to the housing of the drug delivery device and is configured to be directed at the first and second rotating members of the dose setting dosing mechanism of the drug delivery device;
Including the processor, this processor is:
Images of the first and second rotating members are captured on the optical sensor at least at the beginning and end of the drug dose dosing process;
The rotation positions of both the first and second rotating members are determined in each of the captured images;
Dose Setting of Drug Delivery Device The amount of drug delivered by the dosing mechanism is configured to be determined by the rotational position of the first and second rotating members.

The processor is further configured to allow the photosensor to capture images of the first and second rotating members during the drug dosage setting process. The processor is further configured to determine from the captured image whether the drug delivery device is in drug dose dial setting mode or drug dose dosing mode. In the drug dose dial setting mode, the first rotating member rotates in the first direction, the second rotating member remains stationary, and in the drug dose dosing mode, the first rotating member rotates in the first direction. Rotates in the opposite second direction, and the second rotating member rotates in the first direction.

The processor is further configured to identify the coded images associated with each of the first and second rotating members, each coded image encoding a different rotational position of each rotating member.

The least common multiple of the number of unique rotation fixed positions of the first and second rotating members is greater than the maximum dose that can be dialed to the drug delivery device. The maximum dose that can be dialed to the drug delivery device is 120 units.

The processor determines the rotational position of both the first and second rotating members at the beginning and end of the drug dose dosing process and uses the determined position to determine the amount of drug administered. It is composed of.

The first rotating member is a hollow cylindrical number sleeve in which the numbers are stamped on the first portion of the outer surface. The coded image is provided on the second portion of the outer surface. The second rotating member is a gear wheel having a plurality of teeth. A coded image on the gear wheel is marked on the top of the tooth of each gear.

The optical sensor is configured to be activated by the movement of the first rotating member. The optical decoding system also includes a switch. Changes in the state of this switch are configured to activate the photosensor.

The drug delivery device and switch are configured and arranged to change the state of the switch as the drug delivery device moves from a zero unit drug dose arrangement to a one unit drug dose arrangement.

The optical decoding system also includes a display device. The processor is configured to display an indication of the amount of drug delivered to the display device.

The optical decoding system further includes one or more LEDs configured to illuminate a portion of the first and / or second rotating member.

The optical decoding system is part of an auxiliary device configured to be attached to a drug delivery device.

A second aspect of the invention provides a drug delivery system, which is:
A drug delivery device comprising a first and second rotating member in which a plurality of coded images are respectively arranged around the outer surface, each of which corresponds to an individual rotational position of each member. ;
The optical decoding system according to any one of claims 1 to 17, which is held in the housing of the drug delivery device.

In the drug delivery system:
The first rotating member is a hollow cylindrical number sleeve in which the numbers are stamped on the first part of the outer surface;
The coded image on the number sleeve is provided on the second part of the outer surface;
The second rotating member is a gear wheel with multiple teeth;
The gear wheel engages the drive sleeve of the drug delivery device during the drug dose dosing process.

The number of coded images on the number sleeve is 24 and the number of coded images on the gear wheel is 7.

For a more complete understanding of the exemplary embodiments of the invention, see later description in conjunction with the following figures.

2 are two diagrams of a drug delivery device in which a sensor device according to various embodiments of the present invention is used together. 2A-2E are simplified views illustrating various components, and combinations of components, of a drug delivery device, such as those of FIG. 1, in which sensor devices according to various embodiments are used together. Continuation of Fig. 2-1. 3A-3C are simplified views illustrating various components of a drug delivery device in which a sensor device according to various embodiments of the invention is used together. It is sectional drawing which shows the drug dose setting dosing mechanism of a drug delivery device. FIG. 6 is a cross-sectional view showing some components of a drug dose setting dosing mechanism of a drug delivery device for use in the present invention and an outline of an optical sensor arrangement according to an embodiment of the present invention. FIG. 6 is a perspective view showing some components of a drug dose setting dosing mechanism of a drug delivery device for use in the present invention. It is a simplified block diagram of the sensor device by embodiment of this invention. It is a table which shows the rotation fixed position of the rotating member of a drug delivery device at a different drug dose.

The drug delivery device 1 of FIG. 1 is configured to allow the user to adjust the drug dose (ie, the numerical value of the drug dose) scheduled for delivery (ie, dosing) using the device 1. In the example of FIG. 1, this is achieved by rotating (ie, dialing) the dose selector 10 so that the internal dial setting mechanism (not shown) is activated after the drug delivery mechanism (not shown) is activated. , Adjust the amount of drug to be administered. In this example, the drug delivery mechanism is activated by pressing a button 11 on the device.

The drug delivery device 1 includes an outer housing 12 in which at least one aperture, ie windows 13A, 13B, is formed. As will be appreciated, the aperture is simply the cut-out area of the outer housing 12, while the window is the transparent part of the housing from which the components of the device can be seen. For convenience, at least one aperture, ie windows 13A, 13B, will be hereafter referred to simply as at least one window.

At least one window 13A, 13B allows the movable gauge element 14 to be visible from the outside of the housing 12. The drug delivery device is configured to move the movable gauge element 14 when the dose selector 10 is dialed, thereby indicating the selected dose to the user. More specifically, when the dose selector 10 is dialed, the gauge element 14 moves axially along the underlying surfaces 15A, 15B, thereby indicating the selected dose. In the example of FIG. 1, the surface 15A beneath at least a portion of the gauge element 14 includes the number sleeve 15A. The number sleeve 15A has a number indicating the drug dose provided on its outer surface, and the number indicating the currently selected dose is visible through at least one window 13A, 13B. In this example, the number sleeve 15A is visible through a gauge window (ie, aperture) 14-1 formed on the movable gauge element. Other parts of the movable gauge element 14 are discussed below.

The top view of the drug delivery device 1 shown in FIG. 1 shows the state before any dial setting is made. Thus, the movable gauge element 14 is in its first (ie, early) position at the first end of the path through which it can move. In this example, when the movable gauge element 14 is at the first end of its path, the portion of the number sleeve 15A visible through the gauge window 14-1 indicates number zero (ie, zero dose).

The bottom figure of the drug delivery device 1 shown in FIG. 1 shows the state after the dial setting is performed. Therefore, the movable gauge element 14 moves axially from its first position along the path visible from the first window 13A. In this example, device 1 is dialed to its maximum dose so that the movable gauge element 14 is moving to the second end of its path. The maximum dose in this example is "100", so the portion of the number sleeve 15A visible through the gauge window 14-1 indicates the number "100". In some other embodiments, the maximum dose is "120", but the amount of drug or individual dose that can be dialed to the device is not essential.

In this example, device 1 includes first and second windows 13A, 13B. The number sleeve 15A is below the first window 13A and is visible through the first window 13A, whereas the element 15B further down is below and is optionally visible through the second window 13B. Further below element 15B may or may not contain any number. Further below, the surface 15B can be visually distinguished from the second portion 14-2 of the movable gauge element 14, which is configured to overlap and axially move along it. For example, the second portion 14-2 of the movable gauge element 14 has a different reflectance than the surface 15B further below. For example, one of the gauge element 14 and the underlying surface 15B is a light color (eg, made of a brightly colored polymer) and the other is a dark color (eg, made of a darkly colored polymer). ing). Therefore, the user determines the ratio of the second window 13A where the gauge element 14 (specifically, the second portion 14-2) is visible, in comparison to the ratio where the lower surface 15B is visible. , The dose selected can be determined. This can be seen from FIG. 1, in which the gauge element 14 covers the entire length of the path visible through the second window 13B when device 1 is dialed to its zero dose. In contrast, when device 1 is dialed to its maximum dose, the gauge element 14 is not visible through the second window. Instead, a further lower surface 15B is visible along the overall length of the path defined by the second window 13B.

The number sleeve 15A, which is also the surface underneath the gauge element 14, should also be visually distinguished from the movable gauge element 14, which is configured to overlap and axially move along it. Can be done. For example, the gauge element 14 has a different reflectance than the number sleeve 15A. For example, one of the gauge element 14 and the underlying surface 15A is a light color (eg, made of a brightly colored polymer) and the other is a dark color (eg, made of a darkly colored polymer). ing). In the example shown in the figure, the number sleeve 15A and the underlying surface 15B have higher reflectance than the movable gauge element 14.

2A-2E are simplified views of the components of a drug delivery device, such as those in FIG. The purpose of FIGS. 2A-2E is to illustrate the operation of the drug delivery device 1 such as that of FIG. 1; it does not precisely represent the exact structure of the component.

FIG. 2A is a simplified view of the number sleeve 15A. The sleeve 15A is provided with a number on its surface. In some examples, numbers from the minimum dose to the maximum dose are spirally provided around the surface of the number sleeve.

FIG. 2B is a simplified view of the movable gauge element 14. The gauge element 14 includes a first section 14-4 provided with a gauge window 14-1. In this example, the first section 14-4 is a collar configured to surround the numeric sleeve 15A (as can be seen in FIGS. 2C and 2D). A second portion 14-2 and a third portion 14-3 extend in both directions from the first section 14-4. The second and third portions 14-2, 14-3 extend substantially parallel to the longitudinal axis of the number sleeve.

The second portion 14-2 of the movable gauge element extends from the first section 14-4 by a length sufficient to cover the entire second window 13B when the movable gauge is in its first position. It is configured as follows. The second portion 14-2 also functions to cover a portion of the outer surface of the number sleeve 15A when the gauge element moves from its first position. The third portion of the movable gauge element 15-3 is configured to cover a portion of the outer surface of the number sleeve 15A when the gauge element moves between its first and second positions. Thus, only the portion of the numeric sleeve underneath the gauge window 14-1 is visible through the first window 13A of the device housing 12.

The number sleeve 15A is rotatable within the device housing 12 about its longitudinal axis. Therefore, the number sleeve 15A is called a movable (or rotating) member. In some embodiments, the rotation of the number sleeve 15A is caused by the rotation of the dose selector 10.

Axial movement _{G E} rotational movement NS _R and the gauge element 14 of figures sleeve 15A is interdependent. In other words, the dial setting mechanism of the device 1 is configured so that when the number sleeve 15A is rotated, the gauge element 14 moves axially along the path, that is, translates. Further, the degree of rotation of the number sleeve 15A corresponds in proportion to the range of axial motion of the gauge element 14.

FIG. 2C shows the gauge element 14 in its initial position indicating a zero dose in this example. FIG. 2D shows the number sleeve 15A and the gauge element 14 after the number sleeve 15A has rotated and the gauge element 14 has translated from its first position. FIG. 2E shows the arrangement of FIG. 2D in a simplified version of the device housing 12.

FIG. 3A shows an example of a rotating member 65A, which is the number sleeve 65A in this example, which forms part of a drug delivery device 6 for use with the sensor device 2 according to an embodiment of the invention. 3B and 3C show two different simplified views of the delivery device 6 including the rotating element 65A of FIG. 3A. The delivery devices of FIGS. 3A-C are substantially the same as those described with reference to the previous figures, except for the following differences.

Similar to the delivery device 1 described above, the rotation of the rotating member 65A is interdependent with the axial motion of the movable gauge element 14. The degree of rotation is proportional to the axial motion of the movable gauge element 14. In the example of FIG. 3A, the rotating element 65A has a visually identifiable code 66 provided around its outer surface to allow its rotational home position to be determined. For example, the mechanism of the delivery device 1 is arranged such that one full rotation of the number sleeve 15A corresponds to 24 units of dial-set drug. That is, the number sleeve 15A is rotatable to any one of the 24 unique rotation positions. A different code is provided for each of these rotation positions. The code 66 can take any suitable shape as long as it is possible for the sensor device 2 to determine the rotational home position of the rotating element. In this example, the cord 66 is provided at the end of the rotating element 65A.

The housing 12 of the drug delivery device 6 includes another aperture or window 63 in which a portion of the rotating element 65A provided with a portion of the cord 66 on the surface is visible. The other window 63 is arranged and oriented with respect to the rotating element 65A so that a portion of the cord is visible from the outside through the other window 63 regardless of the rotational fixed position of the rotating element 65A. The separate window 63 is positioned and oriented with respect to the rotating element 65A so that a separate section of the cord 66 is visible for each rotation position when the rotating element is rotated by one complete rotation. Another aperture is, in this example, on the side of the device housing 12 separate from at least one window 13A, 13B where the movable gauge element 14 is visible (or if the housing is a cylinder or another circle). (Around the outer surface of the device housing 12). Thus, the movable gauge element 14 does not block the cord from view.

FIG. 4 shows a cross-sectional view of the drug setting delivery mechanism of the drug delivery device 1. Another window 63 is not shown in FIG. As mentioned above, the drug delivery device 1 has two modes of operation: a drug dose dial setting mode and a drug dose delivery (ie, dosing) mode. The drug setting delivery mechanism includes a drive sleeve 72 which is a hollow cylindrical member. The drive sleeve 72 is arranged so as not to rotate during dial setting. A torsion spring 78 is provided, which is secured to the body of the drug delivery device 1 at one end and to the numeric sleeve 15A at the other end. The torsion spring 78 urges the numeric sleeve 15A toward the zero dose position. When the number sleeve 15A is turned to dial the dose, the tension of the torsion spring 78 is further increased. The drive sleeve 72 has a spline connecting interface with the inside of the body of the drug delivery device 1 to prevent relative rotation during dose dial setting. The drive sleeve 72 is also in contact with the clutch member 76 connected to the button 11. When the delivery button 11 is pressed down, the drive sleeve 72 moves longitudinally as a result. As a result, the spline on the drive sleeve 72 is disengaged from the spline on the main body, whereby the drive sleeve is freely rotated. When the button 11 is pushed down, another spline on the drive sleeve 72 engages with the corresponding spline on the number sleeve 15A, thereby rotating the number sleeve 15A under the action of a torsion spring to drive it. The sleeve 72 will also rotate.

The lead screw 80 is provided in the main body of the drug delivery device 1. As the lead screw 80 advances in the axial direction, the drug is discharged from the drug cartridge. The lead screw 80 is rotationally locked to the drive sleeve 72 via a spline coupling interface and is screw coupled to the body of the drug delivery device 1. Therefore, when the drive sleeve 72 rotates during the drug dosing process, the lead screw 80 also rotates and is forced to advance in the axial direction by the screw connection with the main body.

In embodiments of the invention, the drug delivery device 1 includes an additional gear wheel 70, which is not shown in FIG. 4 but is visible in FIG. 5A. The gear wheel 70 is rotatably mounted within the housing and is visible through another window 63. The gear wheel 70 has an integrally molded shaft that is attached to a pin or held in a recess provided in the housing. In some embodiments, the gear wheel is a gear and can engage the corresponding tooth provided at the end of the cartridge of the drive sleeve 72.

The drive sleeve 72 is visible as a cross section in FIG. 5A. The end of the drive sleeve 72, whose teeth are shown on the outer surface, is visible as a perspective in FIG. 5B. The drug cartridge holder 74 is also visible in FIG. 5B.

The drug delivery device comprises an optical sensor arrangement 2 schematically shown in FIG. 5A. The optical sensor arrangement 2 is, in some embodiments, part of an auxiliary device designed to be detachably attached to the drug delivery device 1. In some other embodiments, the optical sensor arrangement 2 is an integral member of the drug delivery device 1. The optical sensor arrangement 2 is arranged so as to capture an image of the gear wheel 70 and a portion of the number sleeve 15A including the visually identifiable code 66, and has a field of view. Optical sensor arrangement 2 captures a single image in which both of these components are visible, or captures images of each component separately, quickly and sequentially.

Several coded images are marked on the outer surface of the gear wheel 70 so that they can be seen in the image captured by the optical sensor arrangement 2. Each of these coded images uniquely encodes the rotational position (ie, the home position) of the gear wheel 70. As such, the image is printed or separately marked on the crown of the tooth or in the valley between the teeth. These coded images can take any suitable shape, for example, they may be barcodes or dot matrices, respectively.

FIG. 6 shows a simplified block diagram of the optical sensor arrangement 2 according to various embodiments. Optical sensor arrangement 2 includes an optical sensor 20, which includes an array of photosensitive elements. These are configured to output a signal to the circuit 21. The circuit 21 can be of any suitable configuration and is suitable for performing the functions described herein by one or more processors and / or microprocessor 210 (for simplicity, hereafter). Includes any combination of (referred to as "at least one processor"). Circuit 21 additionally or otherwise includes any combination of components of only one or more hardware (not shown in FIG. 6) such as ASICs, FPGAs and the like.

Circuit 21 further includes any combination of one or more persistent computer readable memory media 211, such as one or both of ROM and RAM, which is coupled to at least one processor 210. The memory 211 stores the computer-readable instruction 211A. When the computer-readable instruction 211A is executed by at least one processor 210, the functions described in the present specification, such as controlling the operation of the sensor 20 and interpreting the signal received from the sensor, are the optical sensor arrangement 2. Is executed by.

The optical sensor arrangement 2 includes at least one light source 23. The light source 23 is for illuminating the coded information 66 on the numeric sleeve 15A and the coded image on the gear wheel 70. The sensor 20 is configured to read out the coded information by capturing an image. The image is captured by detecting the light reflected from different parts of the surface on which the image is provided. The captured image is then sent to the circuit 21 for interpretation.

The optical sensor arrangement 2 further includes one or both of a display screen 24 (such as an LED or LCD screen) and a data port 25. The display screen 24 can operate under the control of the circuit 21 to display information about the operation of the drug delivery device 1 to the user. For example, the information determined by the optical sensor arrangement 2 is displayed to the user. The information determined by the photosensor arrangement 2 includes the current mode of operation of device 1 and the dose of drug delivered.

The data port 25 is used to transfer stored information about the operation of the drug delivery device 1 from the memory 211 to a remote device such as a PC, tablet computer, or smartphone. Similarly, new software / firmware is transferred to the sensor device via the data port 25. The data port 25 is a physical port such as a USB port or a virtual or wireless port such as an IR, WiFi or Bluetooth® transceiver. The optical sensor arrangement 2 further includes a removable or permanent (preferably rechargeable using, for example, a photovoltaic cell) battery 26 to power other components of the device 2. A photovoltaic power source or a capacitor power source may be used instead of the battery 26.

The optical sensor arrangement 2 captures a large number of images of the number sleeve 15A and the gear wheel 70, from which the drug delivery device 1 is in dial setting mode or delivery mode, and device 1 delivers. When in mode, it is configured to determine how much dose of the drug was delivered. As mentioned above, the gear wheel 70 has teeth that engage the corresponding teeth on the drive sleeve 72. This engagement is always done, or only when the button 11 is pushed down and the drive sleeve 72 moves axially. In either case, the gear wheel 70 also remains stationary during the dial setting because the drive sleeve 72 does not rotate during the dial setting process. The optical sensor arrangement 2 is configured to capture images at regular intervals whenever the dose is dialed, i.e., whenever it is detected that the numeric sleeve 15A is rotating. If any two images show that the number sleeve 15A has moved but the gear wheel 70 has remained stationary, it can be inferred that device 1 is in drug dose dial setting mode. If any two images show that both the number sleeve 15A and the gear wheel 70 have moved, it can be inferred that device 1 is in drug dose delivery mode. The rotation of the number sleeve 15A and the gear wheel 70 in opposite directions during the dose delivery process facilitates the optical sensor arrangement 2 to determine that only the number sleeve 15A is rotating in the dose dial setting mode. Become.

To determine the dose delivered from the drug delivery device 1, the photosensor arrangement 2 compares the images acquired at the beginning of the dose dosing process and at the end of the dose dosing process. The position of the gear wheel 70 before and after the dosing process is compared to the position of the number sleeve 15A at the beginning of the dosing process (the number sleeve 15A is at the end of the dosing if all dial set doses have been drained. Always return to the same position). In some embodiments, the numeric sleeve occupies one of 24 unique rotational positions, but up to 120 units of drug can be dialed to device 1 and delivered from device 1. Therefore, the number sleeve 15A rotates more than one complete rotation. If only the number sleeve is present, it is not possible for the optical sensor arrangement 2 to determine the absolute position of the number sleeve 15A. For example, it is not possible to distinguish between 24 units and 48 units of dialed doses as the number sleeve 15A will be in the same rotational position in these cases. Therefore, it becomes impossible to confidently determine the dose administered.

Therefore, the gear wheel 70 has a different number of teeth. Specifically, the least common multiple of the number of teeth on the gear wheel and the number of unique rotation positions of the numeric sleeve 15A is greater than the maximum dose that can be dialed to device 1. For example, the gear wheel 70 includes seven teeth, the number sleeve 15A has 24 unique positions per revolution, and the maximum dial setting dose is 120 units. The least common multiple of 7 and 24 is 168. In another example, the number sleeve 15A has only 20 unique rotation positions. The maximum dialable dose can be left at 120 units or reduced to, for example, 100 units. In this case, a gear wheel with nine teeth, each with a unique coded image, is used. In general, the number sleeve 15A has an even unique rotation position and the gear wheel 70 has an odd unique rotation position. However, in some embodiments, this arrangement is reversed such that the numeric sleeve 15A has an odd number of unique rotational positions and the gear wheel 70 has an even number of unique rotational positions. The software present in the optical sensor arrangement 2 is configured to separate the two coded images visible in each captured image, whereby the positions of the number sleeve 15A and the gear wheel 70 are accurately determined.

FIG. 7 is a table showing how the optical sensor arrangement 2 can confidently determine the delivered drug dose using the start and end positions of the numeric sleeve 15A and the gear wheel 70. For example, if 3 units are dialed, both the digit sleeve 15A and the gear wheel 70 display a coded image (third unique rotational position of each component) associated with the third tooth. .. If the 27 units are dialed, the digit sleeve will again display the coded image associated with the third tooth, while the gear wheel will display the coded image associated with the sixth tooth. Become. Therefore, the gear wheel 70 makes it possible for the optical sensor arrangement 2 to effectively determine how many times the number sleeve 15A has made a complete rotation.

To reduce power consumption, the optical sensor arrangement 2 is not always powered on, but is "waked up" in response to movement of the dose setting mechanism. The first movement of the number sleeve 15A when the dial setting process starts triggers the optical sensor arrangement 2 to wake up. For example, if the optical sensor arrangement 2 is part of an attachable auxiliary device, the auxiliary device comprises a mechanical sensing pin that will move as the number sleeve 15A moves from the zero dose position to the one unit dose position. When the optical sensor arrangement 2 is integrated with the drug delivery device 1, the sensing pin is internal or is replaced with a conductive, magnetic, capacitive or optical sensor. The "wake-up" signal continues until the drug delivery device 1 switches to drug delivery mode or until it is detected that the rotating member has been stationary for a predetermined period of time.

Alternatively, the photosensor arrangement 2 is configured to capture images only during the drug dose dosing process or at the beginning and end of the drug dose dosing process. Therefore, the trigger wakes up the optical sensor arrangement 2 when the button 11 is pressed down.

Claims (18)

An optical decoding system:
With a single optical sensor that is integral with or attachable to the housing of the drug delivery device and is configured to be directed at the first and second rotating members of the dose setting dosing mechanism of the drug delivery device;
Including a processor, the processor is:
A single photosensor captures one or more images of the first and second rotating members at at least the beginning and end of the drug dose dosing process;
The rotation positions of both the first and second rotating members are determined in each of the captured images;
Dose setting of drug delivery device The amount of drug delivered by the dosing mechanism is configured to be determined by the rotational position of the first and second rotating members ;
The coded images associated with each of the first and second rotating members are identified, and each coded image encodes a different rotational position of each rotating member, where the first and second rotating members. The optical decoding system, wherein the least common multiple of the number of unique rotational fixed positions of the rotating member is greater than the maximum dose that can be dialed to the drug delivery device. The optical decoding system of claim 1, wherein the processor is further configured to allow a single optical sensor to capture one or more images of the first and second rotating members during the drug dosage setting process. The optical decoding system of claim 2, wherein the processor is further configured to determine from the captured image whether the drug delivery device is in drug dose dial setting mode or drug dose dosing mode. In the drug dose dial setting mode, the first rotating member rotates in the first direction, the second rotating member remains stationary, and in the drug dose dosing mode, the first rotating member rotates in the first direction. The optical decoding system according to claim 3, wherein is rotated in the opposite second direction and the second rotating member is rotated in the first direction. The optical decoding system of claim 1 , wherein the maximum dose that can be dialed to the drug delivery device is 120 units. The processor determines the rotational position of both the first and second rotating members at the beginning and end of the drug dose dosing process and uses the determined position to determine the amount of drug administered. The optical decoding system according to any one of claims 1 to 5 , which is configured in 1. The first rotating member is a hollow cylindrical numeric sleeve in which the numerals are stamped on the first portion of the outer surface, and the coded image is provided on the second portion of the outer surface, claims 1-6. The optical decoding system according to any one of the above. The optical decoding system according to any one of claims 1 to 7 , wherein the second rotating member is a gear wheel having a plurality of teeth. The optical decoding system of claim 8 , wherein the coded image on the gear wheel is marked on the top of the tooth of each gear. The optical decoding system according to any one of claims 1 to 9 , wherein the single optical sensor is configured to be activated by the movement of a first rotating member. 10. The optical decoding system of claim 10, further comprising a switch, wherein a change in the state of the switch is configured to activate a single optical sensor. 22. The photoreversion of claim 11 , wherein the drug delivery device and switch are configured and arranged to change the state of the switch as the drug delivery device moves from a zero unit drug dose arrangement to a one unit drug dose arrangement. No. system. The optical decoding system according to any one of claims 1 to 12 , further comprising a display device, wherein the processor is configured to display an indication of the amount of drug delivered to the display device. The optical decoding system according to any one of claims 1 to 13 , further comprising one or more LEDs configured to illuminate a portion of the first and / or second rotating member. The optical decoding system according to any one of claims 1 to 14 , which is a part of an auxiliary device configured to be attached to a drug delivery device. A drug delivery system:
A drug delivery device comprising a first and second rotating member in which a plurality of coded images are respectively arranged around the outer surface, each of which corresponds to an individual rotational position of each member. ;
The drug delivery system comprising the optical decoding system according to any one of claims 1 to 15 , which is held in the housing of the drug delivery device. The first rotating member is a hollow cylindrical number sleeve in which the numbers are stamped on the first part of the outer surface;
The coded image on the number sleeve is provided on the second part of the outer surface;
The second rotating member is a gear wheel with multiple teeth;
16. The drug delivery system of claim 16, wherein the gear wheel engages the drive sleeve of the drug delivery device during the drug dose dosing process. 17. The drug delivery system of claim 17, wherein the number of coded images on the number sleeve is 24 and the number of coded images on the gear wheel is 7.

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